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. 2023 Mar 31;2023(3):CD015130. doi: 10.1002/14651858.CD015130

Tagare 2013.

Study characteristics
Methods RCT
Participants 114 preterm neonates (< 37 weeks') with respiratory distress (Silverman score > 3) up to 6 hours after birth treated with nasal CPAP 6 to 7 cm H₂O (as primary support)
Interventions Bubble (Fisher & Paykel): N = 57
Ventilator (Bear Cub 750): N = 57
Short binasal prongs were used in both groups.
Outcomes Treatment failure (worsening respiratory distress with FiO₂ > 0.6 and CPAP > 8 cm H₂O, recurrent apnoea, "shock", requiring endotracheal intubation and mechanical ventilation)
Mortality before hospital discharge
Duration of CPAP use
Pneumothorax
Nasal trauma (skin erosion/septal injury)
Notes Setting: Pune, India (2008 to 2009)
Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Low risk Sealed, coded envelopes
Blinding (performance bias and detection bias)
All outcomes High risk Open‐label
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome reporting complete.
Selective reporting (reporting bias) Low risk Unlikely (comprehensive)
Other bias Low risk No evidence of an imbalance in baseline demographics